Clinical Data Capture

Clinical Data Capture: Making A Mark In History

Clinical data capture utilizes an electronic or computerized system that is designed for data collection in electronic format mainly for the purpose of human clinical trials.

These electronic systems typically provide a user interface module for clinical data entry, a verification module to check client data, and a reporting medium for data analysis.

Clinical data capture systems are used by pharmaceutical companies, biotechnology and medical devices industries that primarily deal with all facets of clinical research. These systems are particularly beneficial for post-market safety inspection and late phase studies.

Clinical data capture systems also have the capability of increasing data accuracy and decreasing data collection time for medical devices and drugs studies.

Clinical data capture started in the late 1980s. It was, and is still popularly known as Electronic Data Capture or EDC. EDC originated from a different software called RDE or Remote Data Entry.

The clinical data collected during the examination of a new medical device or drug was either administered by nurses, physicians and research coordinators in a medical setting - such as hospitals, clinics, universities and offices- all over the world. Previously, the data collected were just kept on paper and sent to the research sponsor for database entry.

Due to the manual nature of this process, there were inadequacies such as:

- Multiple or duplicate data which produced errors

- Late detection of errors

- Research sponsors were not able to deliver results on time, hence, causing a delayed availability of medical status/data for patients

To address the growing number of concerns, enhanced RDE systems were developed to enable nurses, physicians and research coordinators could enter data directly into the medical settings. This system dramatically improved and produced major benefits like:

- Real time and on the spot data checking that prevents errors and automatically prompts resolutions

- Scheduled data transmission to research sponsors which in turn helped the sponsors in improving their progress and status monitoring of the clinical study and its patients

The drawback to this new RDE system is that there was not enough hardware capacity to house all the incoming clinical data capture. There had to be a way to deploy, install and support every medical investigative site.

Other drawbacks are the costly process and the complication it brought to medical staff. The introduction of laptops helped research sponsors participate in many clinical studies simultaneously. But due to functional and storage constraints, many medical practitioners were dissatisfied.

The rise of the World Wide Web in the mid 1990s, companies found a way to solve the existing issues by developing web-based software. The investigative sites can access the web-based software from their end, and this system represents the new wave of EDC software.

Here are some of the software providers that use the EDC landscape:

- Cmed Research

- Datatrial

- eResearchTechnology

- InterMed Ltd

- Kayentis Digital Pen and Paper CRFs

- Lifetree eClinical

- MedNet Solutions

- Nextrials

- Oracle Clinical

- Phoenix Data Systems

- Quadratek Data Solutions

- S&P data GmbH

- TranSenda

- Unithink

Biotech, contract research and pharmaceutical companies have also developed their own EDC systems.

As technology continues to improve, the need for faster and more enhanced EDC software that can process and support clinical data capture on a real-time basis also increases. Clinical data collection from patient's electronic medical records will be the next innovation in the clinical data capture systems.